Drugs

Evoke to Resubmit Gimoti NDA

Following a 7/25 meeting with FDA, Evoke Pharma says it will resubmit its Gimota (metoclopramide) NDA to the agency in the fourth quarter of 2019. The company says the meeting was to obtain FDA feedback and agreement on the company’s plan to address deficiencies cited in a 4/2019 complete response letter. The focus of the discussion, it says, was on topics in the letter including the root cause analysis of low drug exposure in the comparative bioavailability study and additional product quality/device quality control testing.

Evoke says it will include its root cause analysis and previously collected patient use and experience information in its resubmission package. The company says it also agreed to provide an analysis of pump performance characteristics of the nasal spray devices used in the comparative bioavailability study and three-month stability data from commercial scale batches of Gimoti that the company started manufacturing in 6/2019. FDA did not ask for additional human clinical trials, Evoke says.

Gimoti, a nasal spray formulation of metoclopramide, is being studied for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women, according to Evoke.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome